Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 50
- Latest Decision
- 2022-01-14
Clearances · page 12 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | Covidien, LLC | FJS | Class II | 2022-01-14 |
| K211814 | Wellead Endoscopic Seal | Well Lead Medical Co., Ltd. | ODC | Class II | 2022-01-14 |
| K213095 | andorate Suction Valve, andorate Air/Water Valve | Ga Health Company Limited | ODC | Class II | 2022-01-12 |
| K212954 | G-Tech Wireless Patch System (WPS) | G-Tech Medical | MYE | Class II | 2022-01-10 |
| K212830 | CT3000Pro | Srs Medical | FEN | Class II | 2021-12-21 |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | KDL | Class II | 2021-12-20 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | KNS | Class II | 2021-12-17 |
| K212055 | Connected OR Hub with Device and Voice Control | Stryker Corporation | GCJ | Class II | 2021-12-16 |
| K212675 | Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. | PNG | Class II | 2021-12-14 |
| K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads | Intuitive Surgical, Inc. | NAY | Class II | 2021-12-10 |
| K211309 | endomina system | Endo Tools Therapeutics S.A. | OCW | Class II | 2021-12-07 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | ODG | Class II | 2021-12-06 |
| K212500 | ArtiSential Trocar | Livsmed, Inc. | GCJ | Class II | 2021-12-03 |
| K213116 | Everyway Incontinence Stimulation System | Everyway Medical Instruments Co.,Ltd | KPI | Class II | 2021-12-03 |
| K212950 | FUJIFILM Video Laparoscope EL-R740M30 | Fujifilm Corporaton | GCJ | Class II | 2021-12-02 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | KNS | Class II | 2021-12-01 |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | FJK | Class II | 2021-11-26 |
| K211463 | Regulora | Metame Health, Inc. | QMY | Class II | 2021-11-24 |
| K212150 | Exablate Prostate System | Insightec, Inc. | PLP | Class II | 2021-11-23 |
| K212101 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | 2021-11-23 |
| DEN210012 | vPatch | Virility Medical | QRC | Class II | 2021-11-23 |
| K211347 | Uretero1 Ureteroscope System | STERIS Corporation | FGB | Class II | 2021-11-23 |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | OWN | Class II | 2021-11-22 |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | Arthrex, Inc. | KNW | Class II | 2021-11-19 |
| K211326 | EndoScreener | Chengdu Wision Medical Device Co., Ltd. | QNP | Class II | 2021-11-19 |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | KOD | Class II | 2021-11-19 |
| K212444 | Qora Stool Management Kit | Cm Technologies, Inc. | KNT | Class II | 2021-11-17 |
| K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | PIF | Class II | 2021-11-16 |
| K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America | OWN | Class II | 2021-11-15 |
| K212284 | Disposable Automatic Core Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | KNW | Class II | 2021-11-10 |
| K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | GCJ | Class II | 2021-11-05 |
| K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) | Stryker | GCJ | Class II | 2021-11-04 |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | EZL | Class II | 2021-11-03 |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | PIF | Class II | 2021-11-02 |
| K213195 | Balloon BS-3 | Fujifilm Corporation | FDA | Class II | 2021-10-29 |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | FDF | Class II | 2021-10-22 |
| K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | Pentax of America, Inc. | FDS | Class II | 2021-10-20 |
| K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series | Chongqing Jinshan Science & Technology Co., Ltd. | OCX | Class II | 2021-10-20 |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | FIP | Class II | 2021-10-19 |
| K211224 | RM4 Control Unit | Institut Georges Lopez | KDN | Class II | 2021-10-15 |
| K202688 | AFS Medical Sterile Single-Use Access Port System | Afs Medical Co. , Ltd. | OTJ | Class II | 2021-10-14 |
| K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) | STERIS Corporation | FDI | Class II | 2021-10-07 |
| K210406 | Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. | KGE | Class II | 2021-10-05 |
| K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | FET | Class II | 2021-10-01 |
| K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | Pentax of America, Inc. | PCV | Class II | 2021-10-01 |
| K211593 | Enteral Pump Syringe | Jiangsu Caina Medical Co.,Ltd | PNR | Class II | 2021-09-30 |
| K212747 | Da Vinci SP Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2021-09-29 |
| K203350 | ENDOtube | Nissha Medical Technologies Sas | OCX | Class II | 2021-09-29 |
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | Standard Bariatrics | KNT | Class II | 2021-09-23 |
| K201789 | CT-STOR | Energy Delivery Solutions | NDS | Class II | 2021-09-20 |
| K203141 | Uramix CuraWay Biopsy Needle | Uramix, Inc. | KNW | Class II | 2021-09-17 |
| K211234 | RedEx | Advanced Surgical Concepts, Ltd. | GCJ | Class II | 2021-09-17 |
| K210441 | Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | KPI | Class II | 2021-09-17 |
| K210461 | End Cap | Medical Components Inc (Medcomp) | MSD | Class II | 2021-09-14 |
| K212214 | HandX | Human Xtensions , Ltd. | GCJ | Class II | 2021-09-13 |
| K210625 | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve | Fujifilm Medwork GmbH | ODC | Class II | 2021-09-10 |
| K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | FJK | Class II | 2021-09-06 |
| K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor | STERIS Corporation | ODC | Class II | 2021-09-03 |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | FAJ | Class II | 2021-09-03 |
| K212054 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | 2021-08-30 |
| K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | PNR | Class II | 2021-08-27 |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | NEZ | Class II | 2021-08-27 |
| K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | PKL | Class II | 2021-08-25 |
| K202670 | Nam illumination probe with chopper | Oculight , Ltd. | MPA | Class II | 2021-08-20 |
| K212296 | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 | Fujifilm Corporation | FDS | Class II | 2021-08-19 |
| K202652 | Servator P SALF Solution with THAM | S.A.L.F. Spa | KDN | Class II | 2021-08-19 |
| K203633 | Enteral Extension Sets | GBUK Group, Ltd. | PIF | Class II | 2021-08-19 |
| K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | Mauna Kea Technologies | OWN | Class II | 2021-08-18 |
| K210971 | EnteraLoc Flow | Vonco Products | PIF | Class II | 2021-08-18 |
| K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset | Quanta Dialysis Technologies, Ltd. | KDI | Class II | 2021-08-12 |
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | KNW | Class II | 2021-08-12 |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | 2021-08-06 |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | FAS | Class II | 2021-08-03 |
| K210248 | Lab Bag with Fabric Pouch | Advanced Medical Design Co., Ltd. | GCJ | Class II | 2021-07-30 |
| K200770 | Mini PCNL-System | Trokamed GmbH | FED | Class II | 2021-07-30 |
| K211314 | OCS Lung Solution | TransMedics, Inc. | MSB | Class II | 2021-07-29 |
| K211325 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | 2021-07-27 |
| K211316 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2021-07-23 |
| K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | 2021-07-23 |
| K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | KPO | Class II | 2021-07-23 |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | OTU Medical, Inc. | FGB | Class II | 2021-07-22 |
| K202582 | Arthrex SynergyID Endoscopic Imaging System | Arthrex, Inc. | GCJ | Class II | 2021-07-22 |
| K211933 | EleVation Breast Biopsy System | Bard Peripheral Vascular | KNW | Class II | 2021-07-15 |
| K202922 | END 200 Endoscopic Tubeset | Palliare , Ltd. | FCX | Class II | 2021-07-08 |
| K203575 | GlidePath Retro Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | MSD | Class II | 2021-07-01 |
| K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | KDN | Class II | 2021-07-01 |
| K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | GCJ | Class II | 2021-06-30 |
| K210512 | LUMINELLE DTx System | Uvision360, Inc. | FAJ | Class II | 2021-06-30 |
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | PNR | Class II | 2021-06-30 |
| K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | KNT | Class II | 2021-06-29 |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | PNR | Class II | 2021-06-28 |
| K210138 | iTind System | Medi-Tate , Ltd. | QKA | Class II | 2021-06-25 |
| K202551 | Cor-Knot Micro | Lsi Solutions, Inc. | GCJ | Class II | 2021-06-24 |
| K211595 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | 2021-06-23 |
| K211250 | VisionPort System | New View Surgical, Inc. | GCJ | Class II | 2021-06-21 |
| K210495 | Port Access System | Surgical Innovations Limited | GCJ | Class II | 2021-06-18 |
| K201744 | Su2ura Approximation Device | Anchora Medical, Ltd. | OCW | Class II | 2021-06-17 |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | FFK | Class II | 2021-06-14 |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | Bard Peripheral Vascular, Inc. | MSD | Class II | 2021-06-04 |
| K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) | Mahana Therapeutics, Inc. | QMY | Class II | 2021-06-02 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.